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Clinical Trials/NCT01446029
NCT01446029
Completed
Phase 3

Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease

Minneapolis Veterans Affairs Medical Center1 site in 1 country601 target enrollmentMarch 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Minneapolis Veterans Affairs Medical Center
Enrollment
601
Locations
1
Primary Endpoint
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.

Detailed Description

Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US population has CKD with an increased prevalence among individuals great than 65years. Many individuals with CKD go unrecognized because they are typically asymptomatic. Individuals with CKD have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. Also, individuals with CKD consume a significantly greater proportion of health care expenditures compared to other patients. This study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, ER visits or admission to a skilled nursing facility in patients with CKD compared to usual care. This study will use a randomized controlled trial. Few interventions have been demonstrated to improve clinical outcomes in patients with CKD. If successful, this study will enable the VA to provide high quality care to patients with CKD while potentially reducing the cost of providing care.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Minneapolis Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Areef Ishani

Chief, Section of Nephrology; Associate Professor of Medicine

Minneapolis Veterans Affairs Medical Center

Eligibility Criteria

Inclusion Criteria

  • Enrolled at Minneapolis or St. Cloud Veterans Affairs Health Care System (VAHCS) or affiliated Community Based Outcomes Clinic(CBOC); Late eGFR within the VA system \<60 ml/min/1.73m2 -

Exclusion Criteria

  • Primary care provider unwilling to have participant included in study; unable to give consent; severe mental health condition; living in a nursing home

Outcomes

Primary Outcomes

composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)

Time Frame: one year

Secondary Outcomes

  • reduction of cost(one year)
  • incidence of end stage kidney disease(one year)
  • hospital re-admission(one year)
  • Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin(one year)

Study Sites (1)

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